On July 1, the USPTO published a notice in the Federal Register with guidance regarding the proper presentation of prophetic and working examples in a patent application. Prophetic examples (sometimes referred to as “paper examples”) describe experiments that have not been performed and may also describe predicted or simulated results. A working example, in contrast, is one that describes work actually performed or experimental results actually achieved.
The guidance requires that examples be described to clearly distinguish between prophetic and working examples. According to MPEP 608.01(p), prophetic examples may be written in future or present tense but not in past tense. The guidance advises that the proper tense should be used when describing experiments and results to avoid ambiguity in their interpretation.
A description that results in ambiguity as to whether the example is a working or prophetic example may result in a rejection under 35 U.S.C. § 112 for lack of enablement and/or written description. According to the guidance, the examiner may make such a rejection “[i]f the characterization of the results, when taken in light of the disclosure as a whole, reasonably raises any questions as to whether the results from the examples are actual.”
If such a rejection is made, the applicant may respond by (1) providing actual test results or an example that has been conducted, or (2) providing relevant arguments or a declaration that there is a strong reason to believe the predicted results would be obtained. In doing so, the applicant should not introduce new matter into the application.
The guidance advises that proper tense should be used so that readers can readily distinguish between actual and predicted results. Any ambiguities are to be resolved so that a person of ordinary skill reading the disclosure can rely on the application disclosure as an accurate description of the experiments. To help the reader readily distinguish prophetic and working examples, the guidance states that a best practice is to label examples as prophetic or otherwise separate them from working examples to avoid ambiguity in their interpretation.
Finally, the guidance states that using past tense when describing prophetic examples may raise duty of disclosure and inequitable conduct issues. As required by MPEP 2004, “[c]are should be taken to see that inaccurate statements, inaccurate evidence or inaccurate experiments are not introduced into the record, either inadvertently or intentionally.” Inaccurate descriptions may violate the duty of candor and good faith in dealing with the USPTO, in accordance with 37 C.F.R. § 1.56(a).
Given the serious threat to the enforceability of patents based on the language used to describe the examples, patent drafters and applicants will want to carefully review any examples included in their applications before filing.